UMIN-CTR Clinical Trial

Basic information
Public title	A randomized, open-placebo-controlled crossover study to investigate the relief effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" on acute phase muscle fatigue.
Acronym	The clinical trial for investigation of anti-fatigue effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI".
Scientific Title	A randomized, open-placebo-controlled crossover study to investigate the relief effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" on acute phase muscle fatigue.
Scientific Title:Acronym	The clinical trial for investigation of anti-fatigue effect of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI".
Region	Japan

Condition
Condition	The healthy adults who routinely take exercise.
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical benefits, such as anti-fatigue effect, associated with ingestion of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" for the healthy adult with routinely take exercise.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Maximum rotational speed on 10 seconds high power test by bicycle ergometer at pre- and post- exercise tolerance, four-hour rest after exercise, and the next day.
Key secondary outcomes	1. Fatigue related scales (VAS, modified Borg scale) 2. Fatigue related biochemical examination of blood and urine 3. Amino acid analysis 4. Adverse events. (They are assessed at pre- and post-exercise tolerance, four-hour rest after exercise, and the next day except for adverse events.)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subjects are instructed to take 150 ml of fermented milk beverage made with koji mold named "HYAKUBYAKUKOJI" at the time of pre-exercise tolerance and three times per hour during four-hour exercise.
Interventions/Control_2	The subjects are instructed to take 150 ml of "Pocari Sweat" with 28g of glucose at the time of pre-exercise tolerance and three times per hour during four-hour exercise.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects who are judged as healthy by self-reported health questionnaire. 2. Subjects who routinely take exercise (Average more than one-hour exercise per day). 3. Subjects who have no abnormality in clinical problems by screening tests. 4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria	1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases. 2. Subjects who can't take exercise tolerance by bicycle ergometer. 3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 4. Pre- or post-menopausal women having obvious changes in physical condition. 5. Subjects who are at risk of having allergic reaction to dairy product including milk and rice. 6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 7. Subjects who don't take dairy product and rice even if there is any reason. 8. Subjects who are heavy smoker (more than 21 cigarettes per day), or alcohol addicts (more than 20g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency. 9. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 10. Pregnant or lactating women or women expect to be pregnant during this study. 11. Subjects who have cognitive disorder or who have possibility of the disorder. 12. Subjects who participate and take the study drug in other clinical trials within 12 weeks prior to this study. 13. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Zip code
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuji Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, University of Miyazaki hospital
Zip code
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Homepage URL
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki
Institute
Department

Funding Source
Organization	Hakusuisha Milk Industry Co. Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	宮崎大学医学部附属病院（宮崎県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date	2016 Year 09 Month 29 Day
Last follow-up date	2016 Year 12 Month 14 Day
Date of closure to data entry	2017 Year 01 Month 11 Day
Date trial data considered complete	2017 Year 01 Month 25 Day
Date analysis concluded	2018 Year 05 Month 22 Day

Other
Other related information

Management information
Registered date	2016 Year 10 Month 02 Day
Last modified on	2018 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027869

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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